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Article History

Received: 5 May 2020

Accepted: 11 September 2020

First Online: 13 October 2020

Compliance with ethical standards

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: None of the authors declare a financial conflict of interest. NP, SCK, CLP, HOA, ERM, and NG declare no conflicts of interest. NEM is supported by a Career Development Award from The Medical Research Council (Grant Ref: MR/R008302/1) and is in receipt of a project grant from Bart’s and The London Charity (MGU0465). He has also received consultancy fees and funding for research from ImCheck Therapeutics SAS. AJS research is supported by grants from Gilead Sciences, AbbVie, The Medical College of St Bartholomew’s Hospital Trust, Bowel and Cancer Research, and Bart’s Charity. SCK, NEM, and AJS have done contract work for Parexel pre-dating the work described in this report. At the time of this work and report, Parexel Clinical Trials Unit had a short-term contract with the Antigen Presentation Research Group (APRG) to use a Class II cabinet within the laboratory. The APRG has also been contracted to perform immunological studies by a pharmaceutical company, the tissue specimens for which were supplied on behalf of that company via Parexel which is located adjacent to the APRG department. There is no conflict of interest involved.

: Ethics approval had been obtained for the TGN1412 trial (by the investigators—none of the authors of this report were involved in the clinical trial). At the time of the trial-related serious adverse event, clinical and immune monitoring ensued as a matter of standard clinical care; no studies were done outside what was required for clinical care of the patients. Discussions between the Ethics Committee, MHRA and Expert Scientific Group set-up by the Minister of Health (UK) at the time to investigate the trial outcome unanimously concluded that the monitoring (as outlined in this report) should continue for standard of care, and that specific ethics approval was not required due to the extraordinary circumstances.

: Patients consented to clinical follow-up and immune monitoring. None of the authors of this work were involved with the conduct of the clinical trial or any of the pre-clinical testing of TGN1412. The patient cohort had consented to the TGN1412 first-in-man clinical trial that resulted in the cytokine storm serious adverse event. At the time of the start of sample collection for the current report, the patients had been removed from the trial and were being treated based on clinical need, rather than trial protocol.

: Patients have provided written informed consent to the publication of the clinical follow-up and immune monitoring data.

: As this is a clinical cohort follow-up, and not data provided on a clinical trial, the data are unavailable due to personal privacy protections.